Percutaneous mechanical circulatory support devices in high-risk patients undergoing percutaneous coronary intervention: A meta-analysis of randomized trials

BACKGROUND: Percutaneous mechanical circulatory support devices (pMCSDs) are increasingly used on the assumption (but without solid proof) that their use will improve prognosis. A meta-analysis was undertaken according to the PRISMA guidelines to evaluate the benefits of pMCSDs in patients undergoing high-risk percutaneous coronary intervention (hr-PCI). METHODS: We searched PubMed, EMbase, Cochrane Library, Clinical Trial.gov, and other databases to identify eligible studies. Relative risks (RRs) and 95% confidence intervals (CIs) were calculated for 30-day and 6-month all-cause mortality rates, reinfarction, and other adverse events using a random effect model. RESULTS: Sixteen randomized controlled trials (RCTs) were included in this study. In the pooled analysis, intra-aortic balloon pump (IABP) was not associated with a decrease in 30-day and 6-month all-cause mortality (RR 1.01 95% CI 0.61–1.66; RR 0.88 95% CI 0.66–1.17), reinfarction (RR 0.89 95% CI 0.69–1.14), stroke/transient ischemic attack (TIA) (RR 1.75 95% CI 0.47–6.42), heart failure (HF) (RR 0.54 95% CI 0.11–2.66), repeat revascularization (RR 0.73 95% CI 0.25–2.10), embolization (RR 3.00 95% CI 0.13–71.61), or arrhythmia (RR 2.81 95% CI 0.30–26.11). Compared with IABP, left ventricular assist devices (LVADs) were not associated with a decrease in 30-day and 6-month all-cause mortality (RR 0.96 95% CI 0.71–1.29; RR 1.23 95% CI 0.88–1.72), reinfarction (RR 0.98 95% CI 0.68–1.42), stroke/TIA (RR 0.45 95% CI 0.1–1.95), acute kidney injury (AKI) (RR 0.83 95% CI 0.38–1.80), or arrhythmia (RR 1.52 95% CI 0.71–3.27), but LVADs were associated with a decrease in repeat revascularization (RR 0.26 95% CI 0.08–0.83). However, LVADs significantly increased the risk of bleeding compared with IABP (RR 2.85 95% CI 1.72–4.73). CONCLUSIONS: Neither LVADs nor IABP improves short or long-term survival in hr-PCI patients. LVADs are more likely to reduce repeat revascularization after PCI, but to increase the risk of bleeding events than IABP.